2 Acknowledgments The authors thank the members of the Brain Injury Support Group of Portland for their support and the use of their library. They also thank the Portland State University Capstone students who volunteered their time to help with the project: Heather Brooks, Samantha Cohen, Justin Davis, Cynthia Davis-O Reilly, Julie Geil, Cheryl Matsumura, and Jeana Schoonover. The American Academy of Family Practice provided the model, its Clinical Policy Review Form, on which the authors based their review form for this report. ii Rehabilitation for traumatic brain injury

3 Abstract Objective To examine the evidence for effectiveness of rehabilitation methods at various phases in the course of recovery from traumatic brain injury (TBI) in adults. Specifically, we addressed five questions about the effectiveness of (1) early rehabilitation in the acute care setting, (2) intensity of acute inpatient rehabilitation, (3) cognitive rehabilitation, (4) supported employment, and (5) care coordination (case management). Search Strategy A MEDLINE search (1976 to 1997), supplemented by searches of HealthSTAR (1995 to 1997), CINAHL (1982 to 1997), PsycINFO (1984 to 1997), and reference lists of key articles. Selection Criteria Broad inclusion criteria were defined for screening eligible abstracts. Two reviewers read each abstract to determine its eligibility. Full articles were included if they met methodologic criteria and were relevant to one of the causal links identified for each major question. Specifically, we included all comparative (controlled) studies, as well as uncontrolled series that had information about the short- or long-term outcomes associated with rehabilitation for traumatic brain injury. Data Collection and Analysis We developed an instrument to record data abstracted from each eligible article. The instrument includes items for patient characteristics, interventions, co-interventions, outcomes, study methods, relevance to the specific research questions, and results of the study. We used a three-level system to rate individual studies. Well-designed randomized controlled trials (RCTs) were rated as Class I. RCTs with design flaws, well-done, prospective, quasiexperimental or longitudinal studies, and casecontrol studies were rated as Class II. Case reports, uncontrolled case series, and expert or consensus Rehabilitation for traumatic brain injury iii

4 opinion were generally rated Class III. Comparative studies that met inclusion criteria were critically appraised and summarized in evidence tables. Main Results A total of 3,098 references were specified for inclusion. After removal of duplicates, 569 applied to questions 1 and 2, 600 applied to question 3, 392 applied to question 4, 975 applied to question 5. Eighty-seven articles pertaining to Questions 1 and 2, 114 articles for Question 3, 93 articles for Question 4, and 69 articles for Question 5 passed the eligibility screen. Sixty-seven additional articles were recommended for inclusion by experts, or were obtained from reference lists of review articles. There was weak evidence from Class III studies that early rehabilitation during the acute admission reduces the rehabilitation length of stay. Studies of the intensity of acute inpatient rehabilitation had inconsistent results and used study designs that, despite appropriate use of statistical methods to adjust for severity, had serious limitations because of confounders. Controlled trials of cognitive rehabilitation had mixed results, with the strongest evidence (Class I) supporting the use of prosthetic aids to memory. Well-done, prospective observational studies (Class II) support the use of supported employment within the context of well-designed, wellcoordinated programs. From one Class II clinical trial, there was no support for case management, but two well-done Class II studies supported the use of case management to produce functional improvements. Conclusions Population-based studies are needed to examine the overall impact of TBI and the differences in outcome associated with different rehabilitation strategies. Future studies of cognitive rehabilitation and case management should focus on health outcomes of importance to persons with TBI and their families. iv Rehabilitation for traumatic brain injury

11 Summary Advances in medical technology and improvements in regional trauma services have increased the number of survivors of traumatic brain injury (TBI), producing the social consequences and medical challenges of a growing pool of people with disabilities. Wider awareness of the scope of the problem and its consequences for society has led to rapid growth in the rehabilitation industry. Because of this growth, and particularly because clinical rehabilitation strategies vary widely, many groups are interested in the effectiveness of rehabilitation for TBI. Three questions about the status of brain injury research underlie uncertainty about the effectiveness of rehabilitation services. First, how should fundamental concepts such as recovery, functional status, and disability be defined? Because brain function is highly complex, TBI has an extremely wide range of potential outcomes, including, for example, cognitive deficits, motor disabilities, emotional and social dysfunction, personality changes, and changes in appearance. As a result, therapeutic aims and perspectives vary widely among studies, as do definitions of outcome, making valid comparisons across studies difficult. Second, how should the type and severity of the injury itself be measured? Variation in methods to assess the severity of injury in patients entering rehabilitation make it difficult to estimate the effectiveness of different rehabilitation methods. Third, which therapies are effective, and how can patients best be matched to treatment approaches likely to be effective for them? Today, a person s path to rehabilitation after sustaining brain injury may be determined by the mechanism of injury, the resources of the community, the person s employment or financial status, the consent of the family, or the accuracy of emergency department diagnosis. While a few metropolitan areas have organized referral systems that connect patients with resources and rehabilitation programs, systematic methods for evaluating the needs of persons who have sustained brain injury and referring them to appropriate programs are unusual. Without knowing the efficacy of rehabilitation methods in their specific applications, systematic referral that produces the desired result is not possible. Rehabilitation for traumatic brain injury 1

12 Injury is the leading cause of mortality among Americans under 45 years of age; TBI is responsible for the majority of these deaths. An estimated 56,000 lives are lost in the United States each year to TBI. Motor vehicle accidents, followed by firearms and falls, are the leading causes of death from TBI. Males are 3.4 times as likely as females to die of TBI. About 50 percent of people who sustain TBI are intoxicated at the time of injury. In a recent analysis based on hospital discharge data and vital statistics, the annual incidence of TBI in the United States was estimated as per 100,000. In males, the incidence peaks between the ages of (248.3 per 100,000) and again above 75 years of age (243.4 per 100,000). The incidence in females peaks in the same groups, but the absolute rates are lower (101.6 and 154.9, respectively). These rates underestimate the true incidence of head trauma because patients with milder symptoms at the time of injury are usually not hospitalized. About three-quarters of traumatic brain injuries that require hospitalization are nonfatal. Each year, about 80,000 survivors of TBI will incur some disability or require increased medical care needs. Direct medical costs for TBI treatment have been estimated at $48.3 billion per year, including the costs of acute care hospitalization and the costs of various rehabilitation services. In the years , reports of average length of stay (LOS) for the initial admission for inpatient rehabilitation range from days. In one multicenter study (the Model Systems study), the average rehabilitation LOS was 61 days and the average charge was $64,648 exclusive of physician fees. Total charges averaged $154,256. In more recent studies performed in the early 1990s, rehabilitation LOS and charges were lower, ranging from 19 days and $24,000 for patients with milder injuries to 27 days and $38,000 for those with severe injuries. In the Medicare population in 1994, mean charges for patients admitted for brain injury (excluding stroke) were $42,056. To focus attention on important questions, we characterized the life of an adult survivor of TBI in terms of five phases. The first phase is pre-injury. Medical treatment is divided into the acute (or immediate) treatment phase and the intensive treatment phase, lasting days to weeks. The rehabilitation phase may last months to years. The survivor phase implies the remaining life of the person with TBI and involves continual development and adjustment. This division into phases 2 Rehabilitation for traumatic brain injury

13 clarified the three challenges to assessing the efficacy of rehabilitation discussed above. For each phase, we identified patient populations, interventions, and outcome measures and reviewed the literature to answer key questions identified by technical experts. Reporting the Evidence Two panels of experts worked with the research team to identify key questions in the rehabilitation and survivor phases for adults with TBI. The first panel was composed of two physiatrists, a survivor of TBI, the wife of a survivor of TBI, a state vocational rehabilitation counselor, a neuropsychologist, a psychologist, a clinical coordinator of an outpatient TBI rehabilitation program, and a rehabilitation clinical nurse specialist, all from the Portland, OR area. The second panel was composed of nationally recognized experts in rehabilitation. The panels formulated five questions pertaining to the phases of recovery described above. These questions addressed the effectiveness of (1) early rehabilitation in the acute care setting (timing), (2) intensity of rehabilitation, (3) cognitive rehabilitation, (4) supported employment, and (5) care coordination (case management). For each of these questions, members of the research team worked with panelists to write a brief rationale for the question, define key terms, and specify the relevant patient populations, interventions, and outcome measures that should be examined in the literature review. The questions were: 1. Should interdisciplinary rehabilitation begin during the acute hospitalization for traumatic brain injury? 2. Does the intensity of inpatient interdisciplinary rehabilitation affect long-term outcomes? 3. Does the application of cognitive rehabilitation enhance outcomes for persons who sustain TBI? Rehabilitation for traumatic brain injury 3

14 4. Does the application of supported employment enhance outcomes for persons with TBI? 5. Does the provision of long-term care coordination enhance the general functional status of persons with TBI? Methodology A MEDLINE search (1976 to 1997), supplemented by searches of HealthSTAR (1995 to 1997), CINAHL (1982 to 1997), and PsycINFO (1984 to 1997), produced a total of 3,098 references to be considered for inclusion; of these, 569 applied to questions 1 and 2, 600 applied to question 3, 392 applied to question 4, and 975 applied to question 5. Abstracts of each article retrieved by these searches were reviewed independently by two members of the research team, who applied predefined, broad eligibility criteria. When the two reviewers disagreed, a third reviewer read the abstract and cast the deciding vote on whether it should be included. In the event a reference did not have an abstract, and the title for the reference was not sufficient for determination of status, the article was retrieved and reviewed to determine its eligibility. The two reviewers examined each abstract and indicated whether it met the inclusion criteria and, if not, the reason for exclusion. If the abstract was eligible, or if it did not contain sufficient information to determine eligibility, the full text of the article was retrieved for review in the next phase of the selection process. Eighty-seven abstracts pertaining to questions 1 and 2; 114 articles for question 3; 93 articles for question 4; and 69 articles for question 5 passed the eligibility screen. Sixty-seven additional articles were recommended for inclusion by experts or by review of reference lists of review articles. In all 363 articles were retrieved from the library for review and abstraction. Additional criteria for inclusion were defined separately for each of the five questions; these criteria are described in the results sections concerning each question. The criteria varied because the types of studies required varied from question to question. Articles that applied to more than one question 4 Rehabilitation for traumatic brain injury

15 were maintained as duplicates (or triplicates, etc.) in each question-specific file, so they could be considered for inclusion based on their relevance to each question. Data Abstraction We designed an instrument to record data abstracted from each eligible article. The instrument includes items for patient characteristics, interventions, cointerventions, outcomes, study methods, relevance to the specific research questions, and results of the study. The instrument has two components: the first four pages of the instrument apply to all articles specified for inclusion in the study. The remaining pages are individual instruments that apply to one of the five questions. To abstract an article, a reader used the initial abstraction instrument plus one or more of the five question instruments. The first few questions of the initial abstraction instrument allowed the reviewer to determine if the article actually met the eligibility criteria for inclusion in this report. If an article was determined to be ineligible, it was passed to a second reader for confirmation. The remaining articles were subjected to the full abstraction protocol. Specification of Level of Evidence We used a three-level system to rate individual studies. Well-designed randomized controlled trials (RCTs) were rated as Class I. RCTs with design flaws, well-done, prospective, quasiexperimental or longitudinal studies, and case-control studies were rated as Class II. Case reports, uncontrolled case series, and expert or consensus opinion were generally rated Class III. A well-done, prospective, multicenter or population-based case series can provide valuable information that, in some ways, is more reliable than data from a randomized trial done in a highly selected sample of patients. However, when used to make inferences about effectiveness, an uncontrolled case series is generally classified as Class III, indicating the lowest level of confidence. A gray zone exists between Class II and definite Class III articles. Much of the research in rehabilitation uses quasi-experimental designs. In these observational study designs, control subjects Rehabilitation for traumatic brain injury 5

16 are sometimes identified from a separate patient population. For instance, Aronow and colleagues compared patients undergoing inpatient rehabilitation to a sample of persons with TBI who had been treated in a region of the country where formal inpatient TBI rehabilitation was not available. This was an entirely separate patient group and all the data except outcome measures came from an independent database. The main difficulty with the quasi-experimental design is lack of control over the constitution of the compared groups. Because there is no randomization and generally no control over the details of the selection process through which the patients received their separate therapies, the groups are likely to differ in the frequency of characteristics that are associated with the outcomes of interest. Even when significant efforts are made to match the experimental and the quasi-control groups, significant differences between the groups are still likely to be present. Much of the literature relevant to the five questions addressed in this effort falls into the gray zone between Class II and Class III. For this reason, critical appraisal of key studies played a particularly important role in this review. A number of characteristics of these studies were considered relevant to all rehabilitation questions and were recorded in the data abstraction form. Evaluation of the following factors played a major role in critically appraising these articles: Prospective collection of data. Complete description of parent study population. Large study population size (driven by hypothesis, power, type I error threshold). Study setting a single center, many centers, or population-based. Description of reasons for referral to service being studied. Methods described completely enough to allow study replication. Complete description of rehabilitation technique in question (independent variable). Complete and adequate description of differences between control and experimental groups. Conditions determining whether they did or did not receive the rehabilitation technique in question. 6 Rehabilitation for traumatic brain injury

17 Information about potential confounders, including types and severity of injury, age, and others (including, in some cases, economic status, educational level, lack of family support). Measurement of confounding variables using instruments validated as accurate, sensitive, and reliable. Payer group. Choice of outcome variables that are meaningful to patients as well as caregivers. Use of functional status and other health outcomes rather than surrogate (intermediate) outcomes. Measurement of outcome variables using instruments validated as accurate, sensitive, and reliable. Timing of outcome measurements. Assessment of patient characteristics and outcomes by blinded observer. Use of multivariate statistical analysis: Were interactions sought and controlled for? Were risk estimates calibrated? Were all relevant confounders included as candidate variables? The criteria used to classify articles and the features to be considered in critically appraising them were discussed at the subcommittee, committee, national expert panel, and Aspen Neurobehavioral Conference levels with the goal of maintaining consensus at least on the relative stratification of individual articles. Construction of Evidence Tables Evidence tables were constructed to summarize the best evidence about effectiveness pertaining to each question. No randomized trials and only a few quasi-experimental studies were available for questions 1 and 2. There were a large number of relevant observational studies of important relationships (for example, the relation of patient characteristics to outcome); we chose not to summarize studies that concerned individual causal links or relationships in evidence tables. For question 3, addressing cognitive rehabilitation, 15 randomized controlled trials and comparative studies that met specified inclusion criteria were placed into evidence tables. All comparative studies located for the last two questions, which addressed supported employment and care coordination, were included in evidence tables. Rehabilitation for traumatic brain injury 7

18 Critical Appraisal of Key Articles For each of the five questions, we formed subcommittees of one or two members of the research team and one or two members of the local technical panel. Each subcommittee was chaired by a member of the research team. Key articles relevant to the assigned question were reviewed in-depth by all members of the subcommittees. These reviews were discussed among the various members of the subcommittees, and the results summarized by the chair. This was an effort to ensure that the summary statements on the research questions reflected the expertise and experience of a variety of technical experts with relevant skills and training. These interpretive efforts addressed the methods and results of individual studies, their rating, and their scientific importance. All of the critical articles for the five questions were individually read by the principal investigator. Summaries were presented and discussed with national experts at the Aspen Neurobehavioral Conference in April Findings 1. One small, retrospective, observational study from a single rehabilitation facility supports an association between the acute institution of formalized, multidisciplinary, physiatrist-driven TBI rehabilitation and decreased LOS (acute hospital and acute rehabilitation) and some measures of short-term physiologic (non-cognitive) patient outcome. The level of evidence is Class III. This study concerned adult patients with severe brain injury (Glasgow Coma Scale [GCS] 3-8); there is no evidence from comparative studies for or against early rehabilitation in patients with mild and moderate injury. 2. When measured as the hours of application of individual or grouped therapies, there is no indication that the intensity of acute, inpatient TBI rehabilitation is related to outcome. Because of methodological weaknesses, however, previous studies are likely to have missed a significant relationship if one exists (a Type II error). These studies contained insufficient information about severity of injury and baseline function to ensure the comparability of compared groups. Also, 8 Rehabilitation for traumatic brain injury

19 these studies did not consider the quality of individual treatments, their lack of autonomy in the cognitive realm, and the delivery milieu. One or more of these factors may affect the outcome of care more than the time spent in each modality. Therefore, future research into efficacy of acute inpatient TBI rehabilitation must more adequately measure such factors and include them in their predictive models. Future studies must also employ a wider spectrum of outcome measures, including measurement of outcomes longer after discharge. From a clinical aspect, the evidence does not support equating different TBI rehabilitation delivery systems based on equivalent times of patient exposure to various therapeutic modalities. For example, this analysis would not support predicting that patient benefit would be equal if an equal time spectrum of rehabilitation therapies were delivered at a rehabilitation center as compared to a skilled nursing facility. More detailed analysis of factors involved in predicting response to rehabilitation modalities must be considered in approaching such questions. Additionally, mandating a minimum number of hours of applied therapy for all TBI patients is not supported by the present state of scientific knowledge. The issue of how much of which interventions optimizes recovery in a given type of patient remains inadequately studied. It is certainly reasonable to avoid situations in which patients do not receive potentially beneficial treatment. Based on the above studies, however, defining a minimal rehabilitation program in terms of time of applied therapy is not likely to optimize either therapists time or patient recovery. It is probable that specific basic programs will have to be related to individual patient groups. Developing such algorithms requires further research. Many patients who suffer TBI do not enter acute inpatient rehabilitation. Only one study of the effectiveness of inpatient rehabilitation included a comparison group of patients who did not undergo inpatient rehabilitation. Future studies should compare acute, inpatient rehabilitation to commonly used alternatives to inpatient rehabilitation, such as care in a well-staffed skilled nursing facility or in less intense variations of acute rehabilitation. Very little is known about the outcome of TBI in these settings. Rehabilitation for traumatic brain injury 9

20 3. There is evidence from two small studies (Class I and Class III) that a personally-adapted electronic device and a notebook with alarm wristwatch reduce everyday memory failures for persons with TBI. There is evidence from one study (Class II[a]) that compensatory cognitive rehabilitation (CCR) reduces anxiety and improves self-concept and relationships for persons with TBI. Evidence from two studies (Class I and Class II[b]) supports the use of computer-aided cognitive rehabilitation (CACR) to improve immediate recall on neuropsychological testing, but the clinical importance of this finding has not been validated. 4. Class II evidence indicates that supported employment can improve the vocational outcomes of TBI survivors. Nearly all information about supported employment comes from two bodies of work, each of which used different experimental designs and different models of supported employment. The findings have not been replicated in other settings or by other centers, so the generalizability of these programs remains untested. 5. Very few studies exist on the effectiveness of case management, and the results of these studies are mixed. The only outcome for which there were results in the same direction from two or more studies pertained to changes in vocational status. This was associated with the single casemanager and insurance approach, as well as with the combined nurse and vocational case-manager model. There were conflicting results about the effects of case management on disability or functional status, living status, family impact and other aspects, and some findings were mentioned in only one study. The clinical trial resulted in no functional status changes among case managed subjects, despite an extended period of rehabilitation. However, when two forms of case management were compared, both the single and multiple case-manager/insurance approaches showed significant functional improvements. Future Research 1. Randomized trials of the timing and intensity of early and acute rehabilitation would be useful. Because the patient characteristics that affect outcome also affect the type and level of rehabilitation services delivered, it may be unlikely that any observational study can provide decisive evidence about 10 Rehabilitation for traumatic brain injury

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